epros Gives Update On Androxal With Respect To Recent FDA Advisory Panel Outcome And Announces Upcoming Presentation at Biocentury

Repros Therapeutics Inc.®

today announced that the conclusions of the FDA Advisory Panel that met on Wednesday, September 17, 2014, to discuss the appropriate population suited to testosterone replacement therapy (TRT), were not directly applicable to Androxal®, the Company's leading drug designed for the treatment of secondary hypogonadism, since Androxal® is not a form of testosterone. The FDA panelists voted to recommend that testosterone replacement class label should be revised, narrowing the treatment option to those with indications such as testes, pituitary or hypothalamus impairment, and excluding age-related hypogonadism, which the panel considered as a normal sign of aging. The Company believes that for the majority of hypogonadal men in the general population suffering from secondary hypogonadism, as described in the European Male Aging Study (Tajar et al JECM 2010), their condition is neither idiopathic nor age-related, but is typically associated with obesity. These men typically have functional but under-stimulated testes due to suppressed gonadotropins. The Company believes that Androxal® can restore normal function in the hypothalamic-pituitary-testes (HPT) axis. By raising endogenous testosterone through the use of Androxal®, the Company believes this disorder can potentially be reversed in conjunction with diet and exercise to induce weight loss. The Company further believes that proper diagnosis is imperative before considering treatment. Androxal® is currently the only drug in Phase 3 development to treat secondary hypogonadism. Dr. Frederick Wu, Professor of Medicine and Endocrinology, University of Manchester, Manchester, United Kingdom, and Principal Investigator on the European Male Aging Study, commented, "Although T replacement is a well-accepted indication for the treatment of patients with classical (pathological and irreversible) primary or secondary hypogonadism, there is currently no approved therapy of the much more common (functional and potentially reversible) secondary hypogonadism associated with obesity, irrespective of age. In the majority of these men, traditional T treatment is not only inappropriate because of further suppression of gonadotropins, but indeed may be counterproductive, particularly in those still seeking fertility." Joseph S. Podolski, President and CEO of Repros Therapeutics, will be presenting at the Biocentury's Newsmakers in the Biotech Industry in New York City on Friday, September 26, 2014 at 1:30 PM (ET). A live and archived webcast of the presentation will be available on the "Events" section of the Company's website, http://www.reprosrx.com.